Common medicines such as Panadol, paracetamol, antibiotics, or anti-allergies are just some types that you might often see in medical stores and even in general stores. These medicines, no matter how accessible, still require several approvals from the Ministry of Health and Prevention (MOHAP) prior to its importing, marketing, or selling in the United Arab Emirates (UAE).
The pharmaceutical industry is a profitable one, which means that there has been a lot of interest from multinational and local companies. In order to ensure that these companies are adhering to the right protocols, and selling approved medications, MOHAP vets the companies and their products beforehand. The products that are put on the market have to be registered with MOHAP first and foremost otherwise you will be looking at hefty fines and indefinite license suspension.
Federal Law Number 4 of 1983 regarding the Pharmaceutical Profession and Institutions commonly also referred to as the Pharmacy Law claims that no medicine or pharmaceutical drug shall be circulated unless the product is registered with MOH. There are several prerequisites to be considered prior to import registered and unregistered drugs in the country to sell or market it in hospitals or clinics.
Prerequisites of Pharmaceutical Market Presence in the UAE
In order to start any business, you need permission from regulating bodies beforehand. This is a universal truth because these governing bodies are tasked to ensure a number of factors one of which is quality. In order to import, sell, and market pharmaceutical medicine, you need approval from MOHAP as previously mentioned. However, there are other factors to consider as prerequisites which we will discuss.
Although, in order to be eligible for the process to begin, the company applying must be legally incorporated in the UAE. In addition to that, they also need to be registered with MOH. If you are not planning on registering the company then another viable option is to engage a local distributor or a commercial agent because both of them typically already have registration with the MOH for the import of pharmaceutical products. The agents then register the products on behalf of you and you can save significant time. However, the agents require a nominal fee to do so.
The MOHAP claims that prior to submitting the application, these two conditions must be met:
- Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.
- The applicant must be a medical warehouse licensed by the Ministry of Health and have a valid license.
Pharmaceutical Product Registration in UAE
The pharmaceutical product registration in the UAE is primarily done online through the MOHAP website. The website has a registration process that requires you to insert your email address and a password; this will enable you to access the electronic portal for the registration of pharmaceutical products and other things in the future as well.
Here is a brief explanation of the process:
- Register your account on the MOHAP website
- Open the document detailing the pharmaceutical product registration and fill out the necessary details
- Pay the necessary dues and make sure to meet all the requirements mentioned on the application
- Following the application submission, the technical committees will “deliberate” and submit their recommendations to the competent ministerial committee
- The applicants will then follow up with the Pharmacological Analysis Section at the Drug Department
- After that, the company will then complete all the requirements and submit them on the e-portal
- A technical committee will approve the registration after the re-deliberating of the submission
- If the conditions are met then the Ministry will issue the registration of products
It is worth pointing out that the product registration certificate which is issued by the Ministry is valid for five years. The starting date of the certificate will be from the date of committee approval, however. The locally produced or manufactured pharmaceutical products certificate is valid for one year and will have to be renewed after that.
Requirements for Registration of Pharmaceutical Products in UAE
Since the Pharma business directly impacts the health of the citizens, all countries have a rigorous process to register the products. Oftentimes people outsource the registration work to reputable consultants and that is how chances of a successful approval are also exponentially increased. We at Riz & Mona Consultancy do provide the registration of various products in the UAE.
The documents and things required to successfully register the products are as following:
- The first and perhaps the most important document is the certificate of the product or the certificate of free sales, which is often issued by the competent authority in the origin country
- The certificate must have all the necessary information; the brand name, formulation of the product, among other things
- Next thing which is required is the company address which has already attained rights for the marketing and the manufacturing
- Accurate information of the products such as their shelf life and storage conditions
- Letter which confirms that the product has been sold for at least two years in the country of origin
- Three authentic samples of the product alongside Certificate of Product analysis of them
- Approved internal leaflet certified by the competent authority
- Since the product must be Halal, the Halal certificate is also required from a regulated authority
Although these are the official requirements, the regulating body might require additional certificates and documents to complete the registration process. Since the products must be free from things such as hormones, heavy metals, antibiotics, steroids, pig derivatives, or any substance that can prove harmful to the health — the proof must be attached. These are minute details but they can prove the difference between having your product registered or not. In addition to all of this, things such as the use of Alcohol must be argued over its use case scenario as well.
Here are some of the important questions that have been typically asked by people who are looking for more information regarding the Registration of pharmaceutical products in the UAE.
|Q. How much is the pharmaceutical product registration fee?
A. The application costs AED 100 whereas the registration of a pharmaceutical product for general sales is AED 5,000.
|Q. How long does the application takes to process?
A. Since the process is tedious and has to be thoroughly checked at each stage, it can take up to as long as 45 days.
|Q. What is the target group for a pharmaceutical product registration service with general sales?
A. Typically, drug warehouses and local pharmaceutical manufacturers.
What Riz & Mona Can Do
We are well aware of the complete process of registration of pharmaceutical products due to years of experience in the UAE market. We have already registered a large number of products successfully in Dubai and across the UAE. Do not hesitate to contact our experts by phone at +971 54 582 1012 or send an email to Info@rizmona.com. We will continuously assist you even after the completion of the registration process in case of any issue or requirement.